Biologics

Biologics

BIOLOGICS CONSULTING GROUP, INC.

BCG Delivers Unparalleled Expertise

Biologics Consulting Group, Inc. is the leading regulatory consulting firm in product development and regulatory strategy for Biologics, Drugs, and Medical Devices. For over 20 years, Biologics Consulting Group has supported clients in the preparation and review of CBER, CDER and CDRH regulatory applications, product development strategies, Quality (or CMC) requirements, pre-clinical and clinical study designs, GLP/GCP/GMP audits, and strategic business planning.

BCG PERSPECTIVES

Today’s Challenges Are Tomorrow’s Opportunities

BCG advises a global client base in navigating the dynamic areas of product development and regulatory strategy. We have knowledge and contemporary experience with regulatory pathways and can provide the requisite preclinical, clinical, quality, analytical, manufacturing support to increase your chances for success.

THE BCG ADVANTAGE

Our Difference is Our Consultants

The BCG consulting team is comprised of over 40 consultants with experience as FDA reviewers and senior supervisors, certified FDA inspectors, and senior leaders from the biotechnology industry. Our team brings unparalleled expertise in FDA regulations, with over 20 consultants having prior positions in the Agency and nearly constant contact with multiple review divisions at CBER, CDER, and CDRH. Our understanding of the FDA enables us to bridge the tough decisions to find the right balance of business, scientific, and regulatory in product development.

BCG IS HIRING

BCG is seeking to hire a Regulatory Project Manager as well as a subject matter expert for a non-clincial pharmacology/toxicology Senior Consultant position with at least 5 years of experience with FDA and/or industry. Please visit our Careers page to learn more about the positions, and to submit your resume if interested.